May 30, 2013 (NOT-OD-13-074) -
NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.

The purpose of this FOA is to encourage research
applications that propose to investigate epidemiologic, clinical, social, and
behavioral interventions to improve the identification, prevention,
treatment, and social circumstances of women at risk for or with obstetric
fistula. The purpose of this FOA is not to address service delivery issues
that have been outlined in the obstetric fistula program development
materials distributed by WHO although it is recognized that improving
financial access to care, transportation of women in labor, and obstetric
service coverage is critical for reducing and eliminating the obstetric
fistula rate. Rather, this FOA requests research applications that complement
the programmatic efforts to deliver better and more timely health care during
labor, delivery, and post partum. Obstetric fistula is a critical maternal
and child health issue in developing countries. Multiple approaches
including both improving emergency obstetric care and improved clinical,
social and behavioral care are needed to reduce its toll on women and
children.

Key Dates

Posted Date

March 10,
2011

Open Date (Earliest Submission Date)

May 5, 2011

Letter of Intent Due Date

May 5, 2011

Application Due Date(s)

Standard
dates apply, by 5:00 PM local time of applicant organization.

It is critical that applicants follow the instructions in
the SF
424 (R&R) Application Guide except where instructed to do otherwise (in
this FOA or in a Notice from the NIH Guide for Grants and Contracts).
Conformance to all requirements (both in the Application Guide and the FOA)
is required and strictly enforced. Applicants must read and follow all
application instructions in the Application Guide as well as any
program-specific instructions noted in Section
IV. When the program-specific instructions deviate from those in the
Application Guide, follow the program-specific instructions. Applications that
do not comply with these instructions may be delayed or not accepted for review.

The United Nations Millennium Development Goals (MDG)
include eight goals that all 191 UN member states have agreed to try to achieve
by the year 2015. The United Nations Millennium Declaration, signed in
September 2000 commits world leaders to combat poverty, hunger, disease,
illiteracy, environmental degradation, and discrimination against women. The
MDGs are derived from this Declaration, and all have specific targets and
indicators. The fifth MDG sets to improve maternal health by reducing maternal
mortality and achieving universal access to reproductive health because
improved maternal health is recognized as an important factor in reducing
poverty and illiteracy.

Maternal mortality is a pervasive problem and much worse in
the developing world; more than one-half million women die worldwide in
childbirth each year. The most common causes of maternal mortality include
hemorrhage, sepsis, hypertensive disorders, and obstructed labor. Obstructed
labor is a consequence of social practices that lead to early marriage and
childbearing, of lack of access to skilled birth attendants and hospital
obstetric services, and lack of transportation to services. Consequences of
labor that is obstructed or prolonged can include, among other conditions,
maternal death, fetal death, and obstetric fistula (OF).

OF is a result of the prolonged pressure of the presenting
fetal part on the pelvis over days of labor. The constant pressure interferes
with blood flow and eventually results in tissue necrosis leading to fistulae
most commonly between the bladder and the vagina or additionally to a fistula
between the rectum and the vagina. Complicated cases can involve both types of
fistulae. Every year about 100,000 women are affected by OF and there are
approximately 2 million cases worldwide of women living with fistulae that have
not been repaired. Because urine and feces leak out uncontrollably, these
women, often very young, are ostracized from their villages and families
without good survival strategies. OF is also treatable by surgery, although
access is usually limited. Even after surgery, however, reintroduction of the
women to the family and village can be difficult. A recent scientific
presentation reported that 90 % of the babies born in cases of OF were
stillborn. Additionally, the primary surgical repair success rate was about
70%, secondary about 60% and tertiary about 55%.

Program efforts in developing countries have been lead by
the World Health Organization, which has developed documents to guide
developing countries in the programmatic aspects of reducing OF. Short, medium
and long term goals should include health promotion and awareness and the
provision of high quality basic and comprehensive maternal health services for
all. These national programs should also provide skilled professional to
repair fistulae. These issues are closely linked to ensuring that women have
reproductive rights recognized by policies and regulations which in the end,
will lead to the achievement of the MDG goals. Recognizing that health care
delivery is a critical component to reducing OF, this FOA proposes
complimentary scientific investigations to improve the knowledge base, reduce
complications and improve outcomes from surgical repairs, and to develop social
and behavioral programs to positively develop family and village reactions to
women who have or have had OF.

Although some risk factors are known, the epidemiology of
the population at risk is not clearly delineated. Known risk factors include
service delivery issues such as delay in transport and lack of operating room
availability. Traditional practices of vaginal cutting in labor and female
genital mutilation as well as young age and first pregnancy are also well
identified factors. Beyond these factors, questions remain about
identification of women at risk for whom preventive clinical measures could
prevent fistulae formation. Clinical treatment is addressed differentially in
different settings and can include or not include such elements as antibiotics
and fluid management. The evidence base for risk factor identification and improving
surgical and social outcomes needs expansion through scientific study.

Research Objectives

The purpose of this FOA is not to address service delivery
issues that have been outlined in the obstetric fistula program development materials
distributed by WHO, although it is recognized that improving financial access
to care, transportation of women in labor, and obstetric service coverage is
critical for reducing and eliminating the obstetric fistula rate. Rather, this
FOA requests research applications that complement the programmatic efforts and
investigate epidemiologic, clinical, social, and behavioral interventions to
improve the identification, prevention, treatment, and social circumstances of
women at risk for or with obstetric fistula. Examples of research projects
could include:

Epidemiology

A complete epidemiologic study, preferably prospective, to
identify subgroups either at the facility or community level who are at risk
for OF. Potentially this could include other pelvic floors disorders related
to obstructed or prolonged labor in women of reproductive age. Epidemiologic
studies could also focus on identification of risk factors for surgical
failures.

Clinical

For primary prevention, are there conservative measures that can
reduce the incidence of fistula formation in women who presented with
obstructed labor? For example, this could be at the community level or
facility level and could include use of fluids or antibiotics or catheters.

Studies investigating use of antibiotics which could include type
of medication, length of administration, and timing of administration.

Research on reintroduction of women with repaired fistulae back
into their home environment.

Studies investigating social change to improve the lives of women
with fistulae that have not been repaired. Identification of barriers to reproductive
health services and novel social approaches to delay childbearing for primary
prevention.

Research projects must compliment any local ongoing programs
in emergency obstetric care. Incorporation of sustainable approaches to
interventions will be positively considered. Priority will be given to
projects in areas in the developing world with the highest rates of maternal
mortality and obstetric fistula, such as sub-Saharan Africa.

Section
II. Award Information

Funding Instrument

Grant

Application Types Allowed

New
Renewal
Resubmission
Revisions

The OER
Glossary and the SF 424 (R&R) Application Guide provide details on
these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations,
and the submission of a sufficient number of meritorious applications.

Award Budget

Application budgets are not limited, but need to reflect
actual needs of the proposed project.

Award Project Period

The scope of the proposed project should determine the
project period. The maximum period is 5 years.

NIH grants policies as
described in the NIH Grants
Policy Statement will apply to the
applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions:

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

The following types of Higher Education Institutions
are always encouraged to apply for NIH support as Public or Private
Institutions of Higher Education:

Applicant organizations must complete the following registrations
as described in the SF 424 (R&R) Application Guide to be eligible to apply
for or receive an award. Applicants must have a valid Dun and Bradstreet
Universal Numbering System (DUNS) number in order to begin each of the following
registrations.

All Program Directors/Principal Investigators (PD/PIs) must
also work with their institutional officials to register with the eRA Commons
or ensure their existing eRA Commons account is affiliated with the eRA Commons
account of the applicant organization.

All registrations must be completed by the application due date. Applicant
organizations are strongly encouraged to start the registration process at
least four (4) weeks prior to the application due date.

Eligible Individuals (Project Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Project Director/Principal
Investigator (PD/PI) is invited to work with his/her organization to develop an
application for support. Individuals from underrepresented racial and ethnic
groups as well as individuals with disabilities are always encouraged to apply
for NIH support.

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA
that is essentially the same as one currently pending initial peer review
unless the applicant withdraws the pending application. NIH will not accept any
application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission
Applications from the SF 424 (R&R) Application Guide.

Section
IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application
package associated with this funding opportunity using the “Apply for Grant
Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and
Form of Application Submission

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for
review.

Letter of Intent

Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent application, the information
that it contains allows IC staff to estimate the potential review workload and
plan the review.

By the date listed in Part 1. Overview
Information, prospective applicants are asked to submit a letter of intent
that includes the following information:

Descriptive title of proposed research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

The forms package associated with this FOA includes all
applicable components, mandatory and optional. Please note that some
components marked optional in the application package are required for
application submission. Follow all instructions in the SF424 (R&R)
Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

All page limitations described in the SF424 Application
Guide and the Table of
Page Limits must be followed.

PHS 398 Research Plan Component

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions:.

Resource Sharing Plan

Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome Wide Association Studies (GWAS) as provided in the SF424
(R&R) Application Guide.

Appendix

Do not use the appendix to circumvent page limits. Follow
all instructions for the Appendix as described in the SF424 (R&R)
Application Guide,

Foreign Organizations

Foreign (non-US) organizations must follow policies
described in the NIH Grants
Policy Statement, and procedures for foreign organizations described
throughout the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in
advance of the deadline to ensure they have time to make any application
corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants
across all Federal agencies. Applicants must then complete the submission
process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants
administration.

Applicants
are responsible for viewing their application in the eRA Commons to ensure accurate
and successful submission.

Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.

For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically.

Important
reminders:All PD/PIs must include their eRA Commons ID in the Credential
fieldof the Senior/Key Person Profile Component of the SF 424(R&R) Application
Package. Failure to register in the Commons and to include a valid PD/PI
Commons ID in the credential field will prevent the successful submission of an
electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the Central Contractor Registration (CCR). Additional
information may be found in the SF424 (R&R) Application Guide.

Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for
post-submission materials, as described in NOT-OD-10-115.

Section
V. Application Review Information

1. Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

Overall Impact

Reviewers will provide an overall impact/priority score to
reflect their assessment of the likelihood for the project to exert a
sustained, powerful influence on the research field(s) involved, in
consideration of the following review criteria and additional review criteria
(as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not
innovative may be essential to advance a field.

Significance

Does the project address an important problem or a
critical barrier to progress in the field? If the aims of the project are
achieved, how will scientific knowledge, technical capability, and/or clinical
practice be improved? How will successful completion of the aims change the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers
well suited to the project? If Early Stage Investigators or New Investigators,
or in the early stages of independent careers, do they have appropriate
experience and training? If established, have they demonstrated an ongoing
record of accomplishments that have advanced their field(s)? If the project is
collaborative or multi-PD/PI, do the investigators have complementary and
integrated expertise; are their leadership approach, governance and
organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift
current research or clinical practice paradigms by utilizing novel theoretical
concepts, approaches or methodologies, instrumentation, or interventions? Are
the concepts, approaches or methodologies, instrumentation, or interventions
novel to one field of research or novel in a broad sense? Is a refinement,
improvement, or new application of theoretical concepts, approaches or
methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the
strategy establish feasibility and will particularly risky aspects be
managed?

If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work
will be done contribute to the probability of success? Are the institutional
support, equipment and other physical resources available to the investigators
adequate for the project proposed? Will the project benefit from unique
features of the scientific environment, subject populations, or collaborative
arrangements?

Additional Review Criteria

As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact/priority score, but will
not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research,
the committee will evaluate the proposed plans for inclusion of minorities and
members of both genders, as well as the inclusion of children. For additional
information on review of the Inclusion section, please refer to the Human
Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live
vertebrate animals as part of the scientific assessment according to the
following five points: 1) proposed use of the animals, and species, strains,
ages, sex, and numbers to be used; 2) justifications for the use of animals and
for the appropriateness of the species and numbers proposed; 3) adequacy of
veterinary care; 4) procedures for limiting discomfort, distress, pain and
injury to that which is unavoidable in the conduct of scientifically sound
research including the use of analgesic, anesthetic, and tranquilizing drugs
and/or comfortable restraining devices; and 5) methods of euthanasia and reason
for selection if not consistent with the AVMA Guidelines on Euthanasia. For
additional information on review of the Vertebrate Animals section, please
refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures
proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the
application as now presented, taking into consideration the responses to
comments from the previous scientific review group and changes made to the
project.

Renewals

For Renewals, the committee will consider the
progress made in the last funding period.

Revisions

For Revisions, the committee will consider the
appropriateness of the proposed expansion of the scope of the project. If the
Revision application relates to a specific line of investigation presented in
the original application that was not recommended for approval by the committee,
then the committee will consider whether the responses to comments from the
previous scientific review group are adequate and whether substantial changes
are clearly evident.

Additional Review Considerations

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations

Reviewers will assess whether the project presents
special opportunities for furthering research programs through the use of
unusual talent, resources, populations, or environmental conditions that exist
in other countries and either are not readily available in the United States or
augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in
this section of the application, including 1) the Select Agent(s) to be used in
the proposed research, 2) the registration status of all entities where Select
Agent(s) will be used, 3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and 4) plans for appropriate
biosafety, biocontainment, and security of the Select Agent(s).

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review), will be discussed and assigned an overall impact/priority
score.

Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications
will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of
review by the appropriate advisory council or board. The following will be
considered in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

A final progress report, invention
statement, and Financial Status Report are required when an award is
relinquished when a recipient changes institutions or when an award is
terminated.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants
Policy Statement for additional information on this reporting requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.